Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema

Exclusion Criteria

• •Monocular, or vision worse than 20/400 in the fellow eye
• •Visual acuity worse than 20/200 20/200 and \< 34 letters read in the study eye
• •Use of depot periocular steroids in the study eye within the past 30 days
• •Current use of \>15 mg/day of oral steroids
• •Known steroid responder
• •Ocular hypertension \> 22 mmHg in the study eye or need for more than one medication to maintain IOP \< 22 mmHg.
• •Cup to disc ratio of \> 0.8 in the study eye
• •Prior filtration surgery or glaucoma implant surgery in the study eye
• •Any active ocular infection in either eye
• •History of herpetic ocular infection in the study eye
• •Macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea
• •Macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days
• •Planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment
• •Any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or OCT images
• •Females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study
• •Participation in another investigational trial within 30 days prior to enrollment or during the study period
• •Uncontrolled hypertension (systolic BP \> 160 mm Hg and/or diastolic BP \> 90 mmHg)
• •Uncontrolled diabetes (HbA1c \> 13)
• •Chronic renal failure requiring dialysis or anticipated renal transplant
• •Retinal or choroidal neovascularization in the study eye; anticipated need for panretinal photocoagulation within the next 30 days
• •Macular edema in the study eye known to be due to a cause other than diabetic retinopathy
• •Use of immunosuppressant drugs